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临床试验/NCT03251235
NCT03251235已完成不适用

Neural Effects of Cognitive-behaviour Therapy in Panic Disorder

University of Oxford0 个研究点目标入组 28 人开始时间: 2011年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
28
主要终点
Emotional processing

研究概览

简要总结

Exposure-based cognitive-behaviour therapy (CBT) for anxiety disorders is an effective intervention, but the brain mechanisms driving recovery are largely unknown. In this experimental medicine study, it will be investigated to what degree CBT affects neural markers of anxiety at an early stage of treatment, to identify dynamic mechanistic changes which might be crucial in the process of recovery as opposed to those seen following full treatment completion. Patients with panic disorder will be recruited and randomly allocated to a group receiving 4 weekly sessions of cognitive-behaviour therapy versus a waiting group not receiving any interventions until after the experimental procedure.

详细描述

PURPOSE The primary purpose is to enhance our understanding of the mechanisms essential in effective treatment of panic disorder.

METHODS Design: The present study has a between-subjects design, including a waiting group of participants with panic symptoms and a treatment group of participants with panic symptoms who will receive cognitive-behavioural treatment before being tested.

Participants: Twenty-eight volunteers with panic symptoms will be recruited. For participants who do meet the basic study criteria a phone screening appointment (10 - 30 mins) will be arranged to further screen for relevant inclusion and exclusion criteria. They will then be invited to the Department of Psychiatry for the pre-assessment session.

Treatment: Within the study, the investigators will offer participants a brief CBT course of 4 sessions, offered by the Lupina service. The Lupina Service forms part of the OBMH primary care Counselling & Psychology Service, based at the Warneford Hospital. It provides intensive individual CBT for panic disorder and agoraphobia and is staffed by trained graduate volunteer therapists. Potential therapists are psychology graduates with prior mental health experience, who are given 2 days' intensive training in CBT for panic disorder and agoraphobia by Alison Croft, Consultant Clinical Psychologist. They then receive group supervision of their clinical cases. Service evaluation indicates equivalent clinical outcomes for volunteer therapists relative to qualified clinical psychologists.

Procedure: Participants will be randomly allocated to either the treatment group or the waiting group. On arrival to the pre-assessment session, participants will be given a copy of the information sheet (previously seen during the online screening and e-mailed/ posted to them). They will be invited to fill out the consent form. Screening for past or previous psychiatric illness will be achieved using a structured clinical interview (SCID). In addition, participants will be asked to complete a battery of questionnaires. They will also be familiarised with the procedure occurring on the scanning day. Any outstanding questions the participant has will be addressed. The visit lasts about 1 to 1 ½ hrs. After the pre-assessment, a 4 weeks follow-up appointment (post-assessment) will be arranged with all participants. Half of the participants will be referred for treatment in the LUPINA group during that time. At the post-assessment 4 weeks later, the participants will be asked to come to the OCMR (Oxford Clinical Resonance Imaging) Department at the John Radcliffe Hospital. The visit will last a total of 2½ to 3 hrs and include a scanning session lasting 1 to 1 ½ hrs. Subjective mood will be assessed on the day of the scan using the State form of the State-Trait Anxiety Inventory, a Mood Visual Analogue Scale and the Positive and Negative Affect Schedule. In addition, subjects will again complete the questionnaires from the pre-assessment. After the scan, participants will work on two behavioural computer tasks using emotional faces and word stimuli to assess facial recognition and attention outside the scanner. At the end of the session, patients from the waiting group will be offered the taster-CBT treatment within the LUPINA service.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Basic Science
盲法
Single (Care Provider)

盲法说明

The care provider is not aware of whether a patient is allocated to the treatment group or the waiting group.

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged 18-70
  • Sufficiently fluent in English to understand the task and instructions
  • PDSS score of at least 6
  • At least two full panic attacks or limited symptoms attacks last 4 weeks

排除标准

  • CNS-acting medication (antidepressants within last 6 months, benzodiazepine last 3 days)
  • Current or past history of alcohol/ drug abuse
  • Serious medical conditions (e.g., epilepsy, heart or respiratory problems)
  • Done the task before
  • Waiting group: under current psychotherapeutic treatment
  • Pregnancy
  • Contraindications to MRI e.g. pacemaker, mechanical heart valve, hip replacement, metal implants
  • Severe claustrophobia that limits ability to participate in fMRI scanning

研究组 & 干预措施

Treatment Group

Experimental

Group receives four weekly sessions of CBT prior to experimental testing/ fMRI

干预措施: Cognitive Behaviour Therapy (Behavioral)

Waiting Group

No Intervention

Group receives four weekly sessions of CBT after experimental testing/ fMRI

结局指标

主要结局

Emotional processing

时间窗: Treatment Group: post 4-week CBT treatment, waiting Group: post 4-week waiting

Activation levels in the fear circuit of the brain in response to emotional stimuli (fMRI)

次要结局

  • Clinical symptom severity - Agoraphobic fear (self-report)(Baseline, after 4 weeks treatment/ waiting)
  • Clinical symptom severity - Fear of physical sensations (self-report)(Baseline, after 4 weeks treatment/ waiting)
  • Clinical symptom severity - Global anxiety and depression (self-report)(Baseline, after 4 weeks treatment/ waiting)
  • Clinical symptom severity - Clinical severity and improvement (clinician-report)(Baseline, after 4 weeks treatment/ waiting)

研究者

申办方类型
Other
责任方
Sponsor

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